1. Determination of mean serum creatinine levels in the intervention and control groups on day zero (before treatment) and 72 hours after treatment
2. Determination of mean BUN levels in the intervention and control groups on day zero (before treatment) and 72 hours after treatment
3. Determination of mean urine output in the intervention and control groups on day zero (before treatment) and 72 hours after treatment
Design
Randomized controlled clinical trial
Settings and conduct
Hospitals affiliated to Isfahan University of Medical Sciences, Al-Zahra, Khurshid and Chamran hospitals
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age over 18 years
2. Receiving iodine-containing laxatives
3. eGFR over 60 (using the CKD-EPI formula)
Exclusion criteria:
1. Age over 65 years
2. Concomitant intake of other nephrotoxic drugs (such as vancomycin, aminoglycosides, amphotericin-B, colistin, cisplatin, calcineurin inhibitors)
3. Failure to complete the study by the end of the third day
4. Pregnancy and lactation
Intervention groups
For the case group, 1000 mg of Helilah extract (two capsules) will be administered every 12 hours, starting 6 hours before the patient is injected with contrast material and continuing for 3 days until the patient has completely eliminated the contrast material. The control group will receive only the usual ward protocol, which includes hydration.
Main outcome variables
In this study, changes in Cr, BUN, eGFR, and urinary output are examined as primary outcomes and the incidence of acute renal failure as secondary outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160713028901N8
Registration date:2026-06-22, 1405/04/01
Registration timing:prospective
Last update:2026-06-22, 1405/04/01
Update count:0
Registration date
2026-06-22, 1405/04/01
Registrant information
Name
Shirinsadat Badri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7068
Email address
badri@pharm.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2027-07-22, 1406/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Terminalia chebula extract in preventing contrast media-induced nephrotoxicity
Public title
Terminalia chebula extract in preventing nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Received iodinated contrast agent
eGFR over 60 (using CKD-EPI formula)
Exclusion criteria:
Age over 65 years
Concomitant administration of other nephrotoxic drugs (e.g. vancomycin, aminoglycosides, amphotericin-B, colistin, cisplatin, calcineurin inhibitors)
Failure to complete the study by the end of the third day
Pregnancy and lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence generation will be performed using block randomization with variable block sizes. The randomization sequence will be generated using the Randomization.com software. Block sizes will vary randomly between 6 and 9 to prevent predictability of allocation. The sequences will be placed in sealed, numbered envelopes, and treatment allocation will be determined based on the order of patient enrollment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Faculties of Pharmacy and Nutrition -Isfahan University of Medical
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2026-04-05, 1405/01/16
Ethics committee reference number
IR.MUI.PHANUT.REC.1405.006
Health conditions studied
1
Description of health condition studied
Nephrotoxicity
ICD-10 code
N17.9
ICD-10 code description
Acute kidney failure, unspecified
Primary outcomes
1
Description
eGFR changes
Timepoint
At baseline and at the end of treatment (after 72 hours)
Method of measurement
Calculation with the CKD-EPI formula
2
Description
changes in creatinine serum level
Timepoint
At baseline and at the end of treatment (after 72 hours)
Method of measurement
measuring creatinine level in serum sample
3
Description
changes in BUN level
Timepoint
At baseline and at the end of treatment (after 72 hours)
Method of measurement
measuring BUN level in blood sample
4
Description
changes in urine output
Timepoint
At baseline and at the end of treatment (after 72 hours)
Method of measurement
measuring urine volume
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients will be hydrated before receiving the contrast agent according to the center's guidelines and protocol, as 1 mL/kg/hour of normal saline for 6 to 12 hours before receiving the contrast agent and 1 mL/kg/hour of normal saline for 6 to 12 hours during and after receiving the contrast agent. For the intervention group, 1000 mg of Helilah extract (two capsules) every 12 hours, starting 6 hours before the contrast agent injection for the patient and continuing for 3 days until the contrast agent is completely excreted from the patient.
Category
Prevention
2
Description
Control group: All patients will be hydrated before receiving the contrast agent according to the center's guidelines and protocol, as 1 mL/kg/hour of normal saline for 6 to 12 hours before receiving the contrast agent and 1 mL/kg/hour of normal saline for 6 to 12 hours during and after receiving the contrast agent. The control group will not receive any medication other than the center's standard protocol.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar jarib street, Isfahan, iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7068
Email
badri@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar jarib street, Isfahan, iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7068
Email
badri@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar jarib street, Isfahan, iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7068
Email
badri@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Initially, both inpatients and outpatients will be included in the study; medication will be administered in the hospital for inpatients and at home for outpatients. In both groups of patients, if testing and follow-up are not possible by the third day, the patient will be excluded from the study.
As mentioned in the objectives, urine output will be measured only in inpatients.
When the data will become available and for how long
The start of the data access period will be in October 2027, after the defense of the thesis and the publication of the article resulting from the project.
To whom data/document is available
Researchers, students and teachers working in academic and medical institutions
Under which criteria data/document could be used
In order to design similar studies or use the results of this study for systematic review and meta-analysis of data
From where data/document is obtainable
Online scientific databases, including PubMed, Web of Science, Scopus, and... Website of Central Library of Isfahan University of Medical Sciences, address: https://diglib.mui.ac.ir/ or by sending an email to the corresponding author: badri@pharm.mui.ac.ir
What processes are involved for a request to access data/document
Searching with keywords in scientific internet databases, Search through the title of the project on the website of the digital library of Isfahan University of Medical Sciences. Internet search on the website of the magazine where the article from the project is published